Norditropin (somatropin) adverse event reports that FDA received

Name: Reaction terms in FDA adverse event reports that name Norditropin
Creator: Reported Reactions
License: https://creativecommons.org/publicdomain/zero/1.0/

Name type: Brand name
Generic name: Somatropin
Class: Recombinant human growth hormone

What a report is

A report is not proof that the drug was the cause of the event.

FDA says:

Adverse event reports submitted to FDA do not undergo extensive validation or verification. Therefore, a causal relationship cannot be established between product and reactions listed in a report. While a suspected relationship may exist, it is not medically validated and should not be the sole source of information for clinical decision making or other assumptions about the safety or efficacy of a product. Additionally, it is important to remember that adverse event reports represent a small percentage of total usage numbers of a product. Common products may have a higher number of adverse events due to the higher total number of people using the product.
Source: openFDA, Drug Adverse Event Overview, section "Responsible use of the data". The site read the page on 2 Oct 2026. The data have the reports that FDA received through 30 Jun 2026.

FDA also says:

There is no certainty that the reported event (adverse event or medication error) was actually due to the product. FDA does not require that a causal relationship between a product and event be proven, and reports do not always contain enough detail to properly evaluate an event. The information in these reports has not been scientifically or otherwise verified as to a cause and effect relationship and cannot be used to estimate the incidence of these events.
Source: openFDA, Drug Adverse Event Overview. The site read the page on 2 Oct 2026.

Do not rely on openFDA to make decisions regarding medical care. While we make every effort to ensure that data is accurate, you should assume all results are unvalidated.
Source: openFDA, Response of the drug event API (meta.disclaimer). The site read the page on 2 Oct 2026.

Not medical advice. This site counts what was reported to FDA. Questions about a medicine or device belong with a pharmacist or clinician.

Drug reports received through 30 Jun 2026. Device reports have a separate cutoff, 30 Sep 2026. Why a report count is not a rate.

Reports on file

From January 2004 to June 2026, FDA received 2,892 adverse event reports that name Norditropin. In these reports the drug is a suspect or interacting product.

In the same period, 638 further reports name it only as a concomitant medicine. The counts on this page do not include these reports.

FDA received 184 reports in the 12 months to June 2026 and 119 in the 12 months before. FDA releases FAERS data every quarter, so the newest months are not complete. They grow in later releases.

Of the 1,332,454 drug reports that FDA received in the 12 months to June 2026, 184 (under 0.1%) name Norditropin. Reports for patients aged 2 to 11 were 27% of the reports that name Norditropin and 1.4% of all drug reports.

The number of people who use the product is not in the data. A count is not a rate. A count of reports is not a count of events or of patients, because one event can have more than one report.

There are many instances of duplicative reports and some reports do not contain all the necessary information.
Source: FDA, FDA Adverse Event Monitoring System (AEMS) Public Dashboard. Content current as of 11 Mar 2026. The site read the page on 2 Oct 2026.

Suspect product

FDA records each drug in a report as suspect, concomitant or interacting. This page counts the reports in which Norditropin is suspect or interacting. FDA says:

Any number of the drugs may be marked as suspect if thought to be responsible for one or more of the reactions, but that information is not validated.
Source: openFDA, Drug Adverse Event Overview. The site read the page on 2 Oct 2026.

Data version

openFDA FAERS release of 29 Oct 2026. Reports received through 30 Jun 2026.

Since the last update

FDA says:

Many factors can influence whether or not an event will be reported, such as the time a product has been marketed and publicity about an event.
Source: openFDA, Drug Adverse Event Overview. The site read the page on 2 Oct 2026.

The information in these reports cannot be used to estimate the incidence (occurrence rates) of the events reported.
Source: FDA, FDA Adverse Event Monitoring System (AEMS) Public Dashboard. Content current as of 11 Mar 2026. The site read the page on 2 Oct 2026.

The latest update of the FDA data, recorded on 28 Oct 2026, changed no count of this page.

In April to June 2026, FDA received 54 reports that name Norditropin.
In January to March 2026, FDA received 28.
In April to June 2025, FDA received 44.

April to June 2026 is the latest closed quarter in the data. A closed quarter is a quarter for which the FDA files have most of the reports.

All updates Feed of updates (RSS)

Reaction lookup

These are the reaction terms that the reports record, with the number of reports for each term. Type a term or a plain word to find its count.

What this list leaves out

The table lists the 166 reaction terms that 5 or more reports record. A term with fewer than 5 reports is not in the table.

The site keeps reaction terms for all 2,892 reports.

The site keeps a term for a year only if two or more reports of that year record it.

So a count in the table can be lower than the count of FDA.

Find a reaction term

The table shows the first 50 of 166 terms.

Reaction terms in the reports that name Norditropin, most reports first
Reaction term (MedDRA) and plain meaning	Reports	Share of the 2,892 reports
Headachehead pain	138	4.8%
Hospitalisationadmission to hospital	113	3.9%
Off label useused for a purpose or in a way not on the label	80	2.8%
Deaththe patient died; cause not stated by this term	77	2.7%
Therapy interrupted	68	2.4%
Fatiguetiredness	65	2.2%
Condition aggravatedthe condition being treated got worse	64	2.2%
Arthralgiajoint pain	61	2.1%
Vomitingbeing sick	58	2%
Therapy cessation	56	1.9%
Seizurea fit or convulsion	55	1.9%
Pyrexiafever	48	1.7%
Drug ineffectivethe medicine did not work as expected	46	1.6%
Nauseafeeling sick	46	1.6%
Product use in unapproved indicationused for a purpose not on the label	46	1.6%
Injection site painpain where the injection was given	45	1.6%
Drug dose omissiona dose was missed	44	1.5%
Product storage errorthe product was stored wrongly	44	1.5%
Insomniadifficulty sleeping	41	1.4%
Incorrect dose administeredthe wrong dose was given	40	1.4%
Brain neoplasm	37	1.3%
Malaisegeneral feeling of being unwell	37	1.3%
Pain in extremitypain in an arm or leg	37	1.3%
Product dose omission issuea dose was missed	37	1.3%
Falla fall	36	1.2%
Product dose omissiona dose was missed	32	1.1%
Pneumonialung infection	29	1%
Rashskin rash	29	1%
Weight increasedweight gain	28	1%
Sleep apnoea syndromepauses in breathing during sleep	27	0.9%
Diarrhoealoose or frequent stools	26	0.9%
Painpain, site not specified	25	0.9%
Hypoglycaemialow blood sugar	24	0.8%
Dizzinesslight-headedness or unsteadiness	23	0.8%
Contusiona bruise	22	0.8%
Epilepsy	22	0.8%
Osteochondrosis	22	0.8%
Peripheral swellingswelling of the arms or legs	22	0.8%
Product dispensing error	22	0.8%
Scoliosis	22	0.8%
Urticariahives	22	0.8%
Anxiety	21	0.7%
Astheniaweakness or lack of energy	21	0.7%
Weight decreasedweight loss	20	0.7%
Depressionlow mood	19	0.7%
Injection site bruisingbruising where the injection was given	19	0.7%
Surgeryan operation	19	0.7%
Decreased appetitereduced appetite	18	0.6%
Hypersensitivityan allergic-type reaction	18	0.6%
Aggressionaggressive behaviour	17	0.6%

Download all 166 terms of Norditropin (CSV)

The counts add to more than 2,892 reports, because one report can record more than one term. FDA says:

No individual drug is connected to any individual reaction. When a report lists multiple drugs and multiple reactions, there is no way to conclude from the data therein that a given drug is responsible for a given reaction.
Source: openFDA, Drug Adverse Event Overview. The site read the page on 2 Oct 2026.

The CSV file has the same rows and the same limits. Its last row is a note that says so.

MedDRA term

The person who codes a report selects the preferred term that agrees best with the description of the reporter. The words under a term are the plain meaning that this site gives.

Not the label

The FDA-approved label of a product lists its adverse reactions. See the official pages at the end of this page.

Same ingredient, other names

Reporters write a brand name or a generic name. Each name has its own page and its own count.

Names of Somatropin with a page, in the order generic names, brand names, names as reported
Name	Name type	Reports
Somatropin	Generic name	5,518
Genotropin	Brand name	45,003
Humatrope	Brand name	5,688
Norditropin (this page)	Brand name	2,892
Omnitrope	Brand name	11,243
Serostim	Brand name	752
Zomacton	Brand name	281

Sum of the separately reported names: 71,377. A report that names two of these names is in the sum two times. The sum is not the number of reports for the ingredient.

FDA says:

Additionally, it is important to remember that adverse event reports represent a small percentage of total usage numbers of a product. Common products may have a higher number of adverse events due to the higher total number of people using the product.
Source: openFDA, Drug Adverse Event Overview. The site read the page on 2 Oct 2026.

Importantly, the AEMS data by themselves are not an indicator of the safety profile of the drug or biologic.
Source: FDA, FDA Adverse Event Monitoring System (AEMS) Public Dashboard. Content current as of 11 Mar 2026. The site read the page on 2 Oct 2026.

Outcomes by year

The table gives the outcomes that the reporters gave, in the terms of FDA.

Outcomes in the reports that name Norditropin, by the year of the openFDA file that holds the report

The table continues to the right.

Year of the openFDA file	Reports	Serious	Death	Life-threatening	Hospitalization (initial or prolonged)	Disability or Permanent Damage	Congenital Anomaly/Birth Defect	Other Serious (Important Medical Events)	Not serious
2004	32	29	1	2	18	2	0	10	3
2005	20	19	3	1	11	0	0	8	1
2006	15	15	1	0	7	0	0	7	0
2007	35	34	5	1	14	1	0	21	1
2008	51	51	5	2	25	2	0	36	0
2009	47	46	4	4	20	0	0	28	1
2010	50	50	4	4	20	0	0	37	0
2011	50	47	5	1	27	1	0	20	3
2012	58	57	2	8	24	2	0	34	1
2013	28	22	0	2	9	1	0	14	6
2014	89	80	3	8	44	4	1	34	9
2015	124	104	4	5	44	4	0	66	20
2016	160	71	2	6	27	6	0	45	89
2017	190	93	4	5	45	6	0	52	97
2018	289	117	9	3	52	2	0	66	172
2019	275	84	5	3	49	1	0	37	191
2020	261	173	16	7	105	3	0	69	88
2021	264	204	19	5	110	1	1	89	60
2022	249	190	14	4	79	2	0	109	59
2023	193	135	13	6	45	2	0	88	58
2024	141	115	6	4	30	1	0	94	26
2025	177	148	12	3	47	2	0	107	29
2026	94	68	2	5	25	3	0	46	26

An outcome in a report is not proof that the drug was the cause. The reporter gives the outcome, and FDA does not verify it. FDA says:

The information in these reports has not been scientifically or otherwise verified as to a cause and effect relationship and cannot be used to estimate the incidence of these events.
Source: openFDA, Drug Adverse Event Overview. The site read the page on 2 Oct 2026.

The six headings with the names of FDA are the outcome terms of FDA. A report can have more than one outcome. The columns Serious and Not serious are the two values of the openFDA field serious. For the value serious, openFDA gives this description:

The adverse event resulted in death, a life threatening condition, hospitalization, disability, congenital anomaly, or other serious condition
Source: openFDA, Drug adverse event fields (YAML reference). The site read the page on 2 Oct 2026.

The year is the year of the openFDA file that holds the latest version of the report. It is not always the year in which FDA first received the report. The chart of the next section uses the year of first receipt. The latest year is not complete.

Reports by year and month

Reports that name Norditropin, by the year in which FDA received them

The column of 2026 has an outline, because the year is not complete. It has the reports that FDA received through June 2026 only.

Show the figures of the chart as a table

Reports that name Norditropin, by the year in which FDA received them
Year	Reports
2004	27
2005	21
2006	17
2007	35
2008	51
2009	56
2010	49
2011	49
2012	77
2013	37
2014	88
2015	106
2016	161
2017	189
2018	280
2019	281
2020	264
2021	267
2022	252
2023	190
2024	147
2025	166
2026	82

Reports that name Norditropin, by month, five years to June 2026

FDA releases FAERS data every quarter, so the newest months are not complete. They grow in later releases.

Why a count moves

A count moves for many reasons. The guide gives FDA's words about them.

Patients and reporters

Age of the patient in the reports that name Norditropin
Age	Reports	Share
Under 2	46	1.6%
2 to 11	781	27%
12 to 17	690	23.9%
18 to 44	264	9.1%
45 to 64	227	7.8%
65 to 74	103	3.6%
75 and over	45	1.6%
Age not given	736	25.4%

Sex of the patient in the reports that name Norditropin
Sex	Reports	Share
Female	1,213	41.9%
Male	1,573	54.4%
Unknown or not given	106	3.7%

Type of reporter in the reports that name Norditropin
Reporter	Reports	Share
Physician	722	25%
Pharmacist	477	16.5%
Other health professional	722	25%
Lawyer	3	0.1%
Consumer or non-health professional	763	26.4%
Not given	205	7.1%

Age and sex are as the report gives them. The reporter is the primary source in the report. 54.3% of the reports give the United States as the country.

Reason for use

Reason for use (indication) that the reports of Norditropin record
Indication as recorded (MedDRA)	Reports	Share
Growth hormone deficiency	667	23.1%
Hypopituitarism	457	15.8%
Short stature	91	3.1%
Body height below normal	59	2%
Turner's syndrome	54	1.9%
Small for dates baby	50	1.7%

The reporter fills in the indication, and the field is often empty. Each share is of all 2,892 reports.

Drugs in the same reports

Other drugs that the reports of Norditropin name, in any role, in order of name
Drug	Reports that name the two
Aspirin	23
Cholecalciferol	22
Desmopressin	23
Ergocalciferol	28
Genotropin	23
Hydrocortisone	79
Levothyroxine	70
Levothyroxine sodium	56
Synthroid	78
Testosterone	34

The table has the 10 drug names that these reports name most. Two names in one report says only that the report recorded the two. It says nothing about the part of a product in the event.

FDA says:

Additionally, it is important to remember that adverse event reports represent a small percentage of total usage numbers of a product. Common products may have a higher number of adverse events due to the higher total number of people using the product.
Source: openFDA, Drug Adverse Event Overview. The site read the page on 2 Oct 2026.

Importantly, the AEMS data by themselves are not an indicator of the safety profile of the drug or biologic.
Source: FDA, FDA Adverse Event Monitoring System (AEMS) Public Dashboard. Content current as of 11 Mar 2026. The site read the page on 2 Oct 2026.

Pages near this one

Somatropin same ingredient
Genotropin same ingredient
Humatrope same ingredient
Omnitrope same ingredient
Serostim same ingredient
Zomacton same ingredient
Ngenla same class
Skytrofa same class
Nordiazepam next in the A to Z list
Norelgestromin/Ethinyl Estradiol Transdermal System next in the A to Z list
Nordazepam next in the A to Z list
Norepinephrine next in the A to Z list

These links are for navigation. No count selected them. The class page lists each drug of the class.

Official pages

DailyMed labels for NorditropinThe labels (prescribing information) that have this name, at the National Library of Medicine.
MedWatch Online Voluntary Reporting FormThe online form of FDA for a voluntary report.
MedWatch: The FDA Safety Information and Adverse Event Reporting ProgramThe page of the FDA program that receives reports about drugs and devices.
FDA Adverse Event Monitoring System (AEMS) Public DashboardThe public dashboard of FDA for adverse event reports on drugs and biologics.

The site checked these addresses on 2 Oct 2026. The links open in a new tab.

Cite this page

Reported Reactions. Norditropin: adverse event reports that FDA received. https://reportedreactions.com/drug/norditropin/ Source: U.S. Food and Drug Administration, openFDA Drug Adverse Event (FAERS) files, release of 29 Oct 2026. Reports received through 30 Jun 2026.

Where the data come from

The counts come from the openFDA Drug Adverse Event (FAERS) bulk files, release of 29 Oct 2026. The files have the reports that FDA received through 30 Jun 2026. A drug name is the name on the report. The site matches it to a brand name or a generic name of the National Drug Code Directory of 2 Nov 2026. A class is the pharmacologic class (EPC) of the FDA label.

A report is in the count when it names Norditropin as a suspect or interacting product. The 638 reports that name it only as a concomitant medicine are not in the count. The site does not publish a report narrative, a lot number, a detail of a patient or the identity of a reporter. The record of FDA is the authority. See how the site counts reports, the data sources and the corrections page.

Questions

Do these reports show that Norditropin was responsible for the reactions?

No. FDA says:

For any given report, there is no certainty that a suspected drug caused the event.
Source: FDA, FDA Adverse Event Monitoring System (AEMS) Public Dashboard. Content current as of 11 Mar 2026. The site read the page on 2 Oct 2026.

A reaction can relate to the condition that the drug treats, to other medicines, or to something else.

Is this the list of reactions on the label of Norditropin?

No. It is a count of what people reported to FDA: 2,892 reports from January 2004 to June 2026. The FDA-approved label of a product lists its adverse reactions. The official pages at the end of this page link to the labels.

Who sent these reports?

Consumer or non-health professional (26.4%), physician (25%) and other health professional (25%). These are the types of reporter for the reports that name this drug.

If a manufacturer receives an adverse event report, it is normally required to send the report to FDA.
Source: openFDA, Drug Adverse Event Overview. The site read the page on 2 Oct 2026.

How does a person report an adverse event?

FDA runs MedWatch, a program that takes voluntary reports from health professionals, patients and consumers. The guide on how to report has the links.

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